Generics BulletinHBW InsightIn VivoMedtech InsightPink SheetScrip

Generics Bulletin

Medtech Insight

Orphan, Combo, Pediatric Products Would See More Influence In Proposed US FDA Reorg

Jul 23 2018

• By Derrick Gingery

FDA entrance sign 2016

Related Content

US FDA Sets 'Low Bar' For Meetings With Patients

Apr 26 2018

Not A Loophole? BIO Concerned About Limiting Orphan Designations For Pediatric Subsets of Common Diseases

Mar 05 2018

Rare Disease Integration Into FDA Reviews Will Grow Under PDUFA VI

Jul 18 2016

Combo Product Review Pilot At US FDA Will Offer All Applications Intercenter Consults

Dec 21 2016

US FDA's Patient Affairs Office Is An Office … In Spirit

Nov 17 2017

Opioid Packaging Standards Could Emerge From Dosage Guidelines in Labeling

Dec 12 2017

Gottlieb Adds A No. 2: Sherman Is US FDA Principal Deputy Commissioner

Aug 21 2017

US FDA's Acting Orphan Products Development Director Has Gene Therapy Background

May 06 2018

US Combo Product Designation Appeal Process Limited In Proposed Rule

May 18 2018

Orphan Designations For Cancer Drugs: US FDA Urged To Distinguish Tissue-Agnostic From Tumor-Specific Diseases

May 11 2018

US FDA Might Be Temporarily Headed By Ostroff As Califf Sets His Departure

Jan 05 2017

US FDA's Rare Diseases Program Not Expected To Change With Drug Office Reorg

Jun 28 2018

Additional Topics

United States FDA Leadership Regulation BioPharmaceutical

More from US FDA

More from Agency Leadership

About Us

Meet the TeamOpens in new window
RSS FeedOpens in new window

Contact Us

Customer Service
SubscribeOpens in new window
AdvertisingOpens in new window
Feedback

Terms and ConditionsOpens in new window

Privacy PolicyOpens in new window